Ember
Senior Member
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Created in 2008, Phoenix Rising is the largest and oldest forum dedicated to furthering the understanding of, and finding treatments for, complex chronic illnesses such as chronic fatigue syndrome (ME/CFS), fibromyalgia, long COVID, postural orthostatic tachycardia syndrome (POTS), mast cell activation syndrome (MCAS), and allied diseases.
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To clarify, the question that I'm asking is a factual one about coding. Does this latest version of ICD-10-CM reverse previous versions, replacing ME with CFS at G93.3?
I managed to copy and paste the Public Testimony portion of the days (days end) from the translators box.
At the December AdCom testimony the FDA said (historically) that Hemispherx asked for fast track status 4 times but were turned down because CFS as not a serious or life threatening disease. But you may be asking about under current PDUFA guidelines for accelerated approval?
I think that he meant that the patient population needs leadership to organize this and put it together.
I am not sure that I understand the difference of when Fast Track or Accelerated Approval really is. What i am hoping is that now that the FDA is looking into ME/CFS as a complex serious disease, they might change their attitude toward the speed of approval of potential drugs.